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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

No text entered.

Reporting Groups

Description

LCP-Tacro

The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.

LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.

Prograf (Tacrolimus)

Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

The patient sample was predominantly White (76.8%) and male (65.4%).

Reporting Groups

Description

LCP-Tacro

The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.

LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.

Prograf (Tacrolimus)

Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.

Prograf (tacrolimus): Administered per current product labeling

Total

Total of all reporting groups

Baseline Measures

LCP-Tacro

Prograf (Tacrolimus)

Total

Overall Participants Analyzed [Units: Participants]

268

275

543

Age [Units: Participants]

<=18 years

0

0

0

Between 18 and 65 years

252

247

499

>=65 years

16

28

44

Age [Units: Years]Mean (Standard Deviation)

44.8 (13.29)

46.9 (14.26)

45.8 (13.82)

Gender [Units: Participants]

Female

94

94

188

Male

174

181

355

Ethnicity (NIH/OMB) [Units: Participants]

Hispanic or Latino

74

79

153

Not Hispanic or Latino

194

196

390

Unknown or Not Reported

0

0

0

Race (NIH/OMB) [Units: Participants]

American Indian or Alaska Native

0

1

1

Asian

10

10

20

Native Hawaiian or Other Pacific Islander

1

1

2

Black or African American

10

15

25

White

203

214

417

More than one race

0

0

0

Unknown or Not Reported

44

34

78

Region of Enrollment [Units: Participants]

Argentina

1

1

2

Singapore

1

1

2

United States

67

70

137

Spain

24

21

45

New Zealand

2

3

5

Poland

27

26

53

Brazil

29

29

58

Mexico

27

29

56

Italy

6

6

12

Australia

11

11

22

France

35

38

73

Serbia

6

5

11

Germany

32

35

67

Body Mass Index [Units: Kg/m^2]Mean (Standard Deviation)

25.72 (4.648)

26.68 (4.948)

26.21 (4.822)

Diabetes at the time of transplant [Units: Participants]

Patients with diabetes at transplant

50

56

106

Patients without diabetes at transplant

218

219

437

Time from transplant to first dose [Units: Hours]Mean (Standard Deviation)

For the 24-month Analysis, the Endpoint Includes Additional Treatment Failures That Occurred During the 12-month Treatment Extension Period, up to Day 734 After the Randomization Date. [ Time Frame: 734 days ]

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.